1. Field of the Invention
The present invention relates to unique formulations for treating inflammatory bowel disease (IBD), such as ulcerative colitis, including 5-amino salicylic acid (5ASA) and a phospholipid.
The present invention relates to unique compositions of matter including 5ASA and phospholipid adapted to release 5ASA in a distal small intestine and/or colon, where lesions due to colitis or Inflammatory Bowel Disease (IBD) are present in order to enhance the anti-inflammatory efficacy of 5ASA. In certain embodiment, the phospholipid composition including from about 15 wt. % to about 95 wt. % of phosphatidylcholine (PC) in a bio-compatible carrier and/or resin. The present invention also relates to methods for making and administering the compositions of this invention orally, enterally and/or rectally.
2. Description of the Related Art
For a background of phospholipids and anti-inflammatory pharmaceuticals the reader is directed to U.S. Pat. Nos. 4,918,063; 5,043,329; 4,950,656; 5,032,585; 5,763,422; and 5,955,451 and PCT/US01/51605, incorporated herein by reference.
Inflammatory Bowel Disease (IBD) represents a family of ulcerative diseases including Ulcerative Colitis and Crohn's Disease that affect the colon and distal small bowel. These diseases are manifested by episodes of GI bleeding, diarrhea, fever, infection and in the most advanced cases, GI fistulation are manifested by perforation and cancer. 5ASA has been used medically to manage patients with IBD, though its effectiveness to keep patients in remission has been limited.
Although 5ASA is an effective treatment, there is a need in the art for 5ASA preparations having improved efficacy to treat IBD and to keep patients in remission.